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OpenTrials
Completed

NCT Number: NCT01286181

Device-guided Breathing for Shortness of Breath in COPD

Although drug therapies and pulmonary rehabilitation have greatly improved COPD symptoms, as many as 50% of patients with severe COPD have inadequately controlled dyspnea. Device-guided breathing is a behavioral intervention that guides respiratory rates into a therapeutic range; prolongation of the expiratory phase improves hyperinflation, the most significant driver of dyspnea in this population. Device-guided breathing, has no known side-effects, and may represent a cost effective adjunctive treatment for dyspnea in severe COPD.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Dyspnea Hyperinflation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current or former cigarette smokers of at least 10 pack-years
  • Clinically significant dyspnea, as determined by a score of at least 2 on the Medical Research Council Dyspnea Score questionnaire (0-4), or through pulmonary function test results of a residual volume (RV) of > 150% predicted or an FEV1 of <65% predicted
  • Clinical diagnosis of chronic obstructive pulmonary disease

Exclusion criteria

  • Unable to use the slow-breathing device due to hearing impairment
  • Poor motivation or lack of interest in using the device
  • Pulmonary Rehabilitation ordered as a new therapy at the time of enrollment

Treatment and study plan

Twice daily practice of device-guided slow breathing.

Behavioral

Participants are asked to use the slow-breathing device for 20 minutes twice daily, for 8 weeks. Participants receive weekly telephone calls to monitor device use and are encouraged to use pursed-lips when following the breathing tones of the device while exhaling.

Primary outcomes

  1. Determine effect of increased device-guided breathing on health-related quality of life measures.

    Time frame: 8 weeks

    Pre and post device use measures of dyspnea, health-related quality of life, stress, adn self-efficacy for managing chronic disease will be obtained through self-administered questionnaires.

Secondary outcomes

  1. Evaluate effect of device-guided slow breathing on daily physical activity.

    Time frame: 8 weeks

    Evaluate the effect of a higher intensity of device-guided breathing (20 minutes twice daily for 8 weeks) on daily physical activity, as measured by a gold-standard activity monitor, before and after device use.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Device-guided Slow Breathing in COPD Patients With Clinically Significant Dyspnea: Phase 2

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 31, 2011
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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